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NCT00473564 · REGISTRY CONDITION SEARCH

Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2016-03-08

To evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions

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outcome · POSTED

Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Head and neck lesions requiring surgical resection, biopsy, or invasive treatment; * Lesion amendable to robotic assisted surgery treatment; * Age \> 19 years; * Patient must sign informed consent. Exclusion Criteria: * Psychological condition that renders the patient unable to understand the informed consent; * Poor mouth opening, with maximal opening less than 1.5 cm.
healthy Volunteers
false
minimum Age
20 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
    intervention Names
    1. Procedure: da Vinci® Robotic System
    label
    TORS Candidates
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. TORS Candidates
    description
    Head and Neck Surgery using the da Vinci® Robotic System
    name
    da Vinci® Robotic System
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
170
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Number of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions
    measure
    Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions
    time Frame
    Intraoperatively average of 2 hours
secondary Outcomes
  1. description
    Assessment of patient safety evaluating the number of participants who experienced known complications from the use of the da Vinci® Robotic System during surgery, who experienced a need for conversion to open surgery during the procedure, or who required additional surgery for re-excision of the lesion due to positive margins
    measure
    Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.
    time Frame
    3 - 24 months postoperatively
Full study description
brief Summary
To evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time.
detailed Description
This trial is a single institution non-randomized study to evaluate the efficacy and safety of the da Vinci® Robotic Surgical System. This study will evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time. This is a robotic system used by surgeons to perform surgery in a less invasive manner.
Source references
references
  1. citation
    Dean NR, Rosenthal EL, Carroll WR, Kostrzewa JP, Jones VL, Desmond RA, Clemons L, Magnuson JS. Robotic-assisted surgery for primary or recurrent oropharyngeal carcinoma. Arch Otolaryngol Head Neck Surg. 2010 Apr;136(4):380-4. doi: 10.1001/archoto.2010.40.
    pmid
    20403855
    type
    DERIVED
  2. citation
    Iseli TA, Kulbersh BD, Iseli CE, Carroll WR, Rosenthal EL, Magnuson JS. Functional outcomes after transoral robotic surgery for head and neck cancer. Otolaryngol Head Neck Surg. 2009 Aug;141(2):166-71. doi: 10.1016/j.otohns.2009.05.014.
    pmid
    19643246
    type
    DERIVED
  3. citation
    Boudreaux BA, Rosenthal EL, Magnuson JS, Newman JR, Desmond RA, Clemons L, Carroll WR. Robot-assisted surgery for upper aerodigestive tract neoplasms. Arch Otolaryngol Head Neck Surg. 2009 Apr;135(4):397-401. doi: 10.1001/archoto.2009.24.
    pmid
    19380364
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-3dac922f4674b3e6ac55
      requested nct id
      NCT00473564
      primary nct id
      NCT00473564
      source kind
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      source record id
      Source null
      source file sha256
      cd92c144c33b33e75a38086ce6cbd6e62d34b7ba84c72dacac16e6781439e40e
      payload sha256
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      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-3dac922f4674b3e6ac55
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
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      occurrences
      1. context exact
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        end
        11
        exact text
        NCT00473564
        start
        0
      offset unit
      unicode_code_points
      query cond
      Hypopharyngeal Cancer
      query disease state id
      ds-hypopharyngeal-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-hypopharyngeal-cancer-000.json
      source file sha256
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      source json pointer
      /studies/76/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      8b88998ff9087e8830563564eb435afabf432e51a014bb6bc39200b1669704b1

    Preserved source evidence · Not medical advice